Trial Outcomes & Findings for Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation (NCT NCT05614011)
NCT ID: NCT05614011
Last Updated: 2024-02-28
Results Overview
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
877 participants
Primary outcome timeframe
One hour
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
Subjects 18+ Years of Age
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril.
|
|---|---|
|
Overall Study
STARTED
|
877
|
|
Overall Study
COMPLETED
|
877
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Baseline characteristics by cohort
| Measure |
Subjects 18+ Years of Age
n=877 Participants
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril.
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
727 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
143 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
560 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
317 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
358 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
43 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other/Multiple Selections
|
386 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Do Not Wish To Disclose
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
877 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: One hourThe acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Outcome measures
| Measure |
Subjects 18+ Years of Age
n=877 Participants
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril.
|
|---|---|
|
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
|
130 Participants
|
PRIMARY outcome
Timeframe: One hourThe acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
Outcome measures
| Measure |
Subjects 18+ Years of Age
n=877 Participants
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril.
|
|---|---|
|
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
|
736 Participants
|
Adverse Events
Subjects 18+ Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place